DIDGET WORLD REPORTS

K093930 · Bayer Healthcare, LLC · NBW · Mar 12, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093930
• Device Name: DIDGET WORLD REPORTS
• Applicant: Bayer Healthcare, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 12, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

The DIDGET World Reports Diabetes Management Software is intended for use by patients with diabetes to track and manage their blood glucose data. The software is designed to be used in conjunction with the DIDGET blood glucose meter to download, store, and display blood glucose results.

Device Story

Software application; transfers blood glucose results, time, date, and data markers from Bayer DIDGET® blood glucose meter to DIDGET® World Reports web server via USB cable. Used by patients with diabetes and healthcare professionals in home or clinical settings. Transforms raw meter data into five report formats: electronic logbook, glucose trend by date, daily blood glucose trend (standard day), weekly blood glucose trend (standard week), and summary charts (histogram/pie chart). Enables visualization of glucose data to assist in diabetes management and clinical decision-making.

Clinical Evidence

Performance assessed in a study of 50 subjects: 3 healthcare professionals and 47 lay users (35 young adults with diabetes, 12 parents/guardians of children with diabetes). Study demonstrated ease of use and understandability of results for the target user population.

Technological Characteristics

Web-based software application; connectivity via USB cable for data transfer from blood glucose meter. No changes to fundamental scientific technology compared to predicate. Software-based data management and reporting system.

Indications for Use

Indicated for patients with diabetes to track and manage blood glucose data using the DIDGET blood glucose meter.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• GLUCOFACTS® Express Diabetes Management Software (k082486)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k093930

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the DIDGET World Reports Diabetes Management Software:

1. The name and 510(k) number of Bayer Healthcare LLC's previously cleared device, GLUCOFACTS Express Diabetes Management Software, cleared under k082486. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION (S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for having the software to reside on a web server as opposed to a user's PC. Additionally it is compatible only with the DIDGET meter, does not change meter settings and does not have a PDF print function.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.